The present invention relates to an invasive medical apparatus fixation and infection control device for medical and veterinary use and more particularly to a device designed to occlude microorganisms from an apparatus penetration site, effectively limit movement of an invasive medical apparatus at its site of penetration, and to automatically deliver controlled amounts of antiseptic, antibiotic, or other medically active substances to the penetration site.
In many conventional medical procedures, invasive medical apparatus are used to provide access to internal organs, body cavities, and vasculature. Invasive medical apparatus are commonly used to provide routes for the administration of medications or fluids, to provide urinary bladder drainage, to provide for drainage from a fluid filled cavity, to provide ventilation through a tracheostomy site, to provide drainage from pustules and abscesses, to provide monitoring access for measuring renal, cardiac, and other physiological parameters. Invasive medical apparatus commonly penetrate the epidermis by means of existing orifices such as the urethral meatus or nares, and by insertion through the epidermis by puncture or surgically created apertures.
Since invasive medical apparatus entrance sites constitute a breach in the body's epidermal defense barrier, a finite risk of infection exists at a penetration site. The use of catheters and other invasive apparatus is the largest source of infections acquired in hospitals and nursing homes. Such nosocomial, iatrogenic, or induced infections occur much more frequently when invasive medical apparatus are left in place more than a few days. This is so because, after a few days, the pumping or sliding movement of the invasive medical apparatus with respect to the penetration site carries microorganisms through the epidermal barrier to cause infections.
There is a direct relation between the length of time an invasive medical apparatus must remain in place and the likelihood of an infection progressing. One of the reasons for this increase in the incidence of infection is the phenomenon of microbial infiltration along the outside surface of an invasive medical apparatus through the epidermis at the puncture point. This is accomplished by the inexorable deposition and advancement of bacteria within a polysaccharide biofilm in the absence of antiseptic, antibiotic, or antimicrobial substances directly at the skin penetration site.
Various methods and devices for preventing microbial infiltration and the concomitant infection focus upon attempting to immobilize an invasive medical apparatus at its penetration site and/or the application of antiseptic or antibiotic substances to the penetration site. However, before the present invention, there was no method or device which combined the characteristics of the present invention to effectively reduce or eliminate infections associated with the use of invasive medical apparatus.
Conventional surgical tape is commonly used to immobilize an invasive medical apparatus with respect to its penetration site. However, this method simply does not prevent slight in-and-out movements of the invasive medical apparatus with respect to the epidermis caused by patient motion and thus allows exposure of the penetration site to infecting microorganisms. The application of antiseptic or antibiotic substances at the penetration site also has a very limited efficacy with respect to devices before the present invention because there has been heretofore no mechanism for maintaining an effective amount of a medically active substance at the site.
Various means and methods have been developed to approach the problems inherent in invasive medical apparatus and catheter entrance and skin puncture sites. U.S. Pat. No. 3,782,377 to Rychlik discloses the use of a flanged infusion needle puncture site shield having a disinfectant impregnated wick-like member for contacting skin near a puncture site. The shield of Rychlik is made of transparent material for observation of the skin near a puncture site. Rychlik does not, however, effectively immobilize the needle with respect to the entrance site nor does it occlude microorganisms.
U.S. Pat. No. 3,683,911 to McCormick discloses an adhesive backed shield provided with a tubular sleeve defining a passageway for a catheter. The invention of McCormick is also provided with an access slit and adhesive for surrounding a catheter and affixing the shield thereto after the catheter has been inserted into a puncture site. McCormick does not disclose the use of a medically active substance or an effectively occlusive seal against microbial infiltration.
U.S. Pat. No. 4,645,492 to Weeks disclose a device for anchoring catheter tubing to the skin of a patient by means of both adhesive and sutures wherein the in-and-out movement of the catheter is restricted by an arcuate passageway and a locking pawl. Weeks does not disclose the use of a medically active substance nor does it provide an effective seal against microbial infiltration.
U.S. Pat. No. 4,519,793 to Galindo discloses an invasive medical apparatus fixation device particularly adapted for use with ostomy receptacles having a funnel-like tube holding member which is conformable to restrict the movement of a medical tube by frictional means and also having a base provided with an adhesive for attachment to a receptacle surface. Galindo is not adaptable to use with invasive apparatus, however.
U.S. Pat. No. 3,900,026 to Wagner discloses a guard for intravenous needles which comprises a flanged needle entry site housing provided with means for locking a needle to a supply tube and which is adapted to be affixed to a body surface by flanges having adhesive thereon or by supplemental means such as tape. The device of Wagner is transparent for puncture site inspection and is not intended to be use with a medically active substance provided in the chamber formed by the device and the skin while in use. Wagner also lacks means for providing an effective seal against microbial infiltration.
U.S. Pat. No. 4,397,641 to Jacobs discloses a catheter support device for anchoring an intravenous catheter which comprises a rigid annular support member which can be adhesively secured around a puncture site. Jacobs is further provided with means for restraining a portion of the medical tubing leading to a puncture needle thus mechanically isolating disruptive forces transmitted through the catheter from that portion of the catheter tubing which is adjacent to and connected to an infusion needle. Jacobs does not, however, provide any seal whatsoever directly around the puncture site, nor does it contribute a medically active substance to the site.
U.S. Pat. No. 4,767,411 to Edmunds discloses a protective catheter sleeve provided with an open-ended flanged housing wherein the housing is adapted to be adhesively attached to a body surface to form a chamber for receiving and storing antiseptic fluid. Edmunds is also provided with a needle access port in the flanged housing and a slit for the installation and removal of the device from around an indwelling catheter. The housing of Edmunds provides a chamber when in position around an indwelling catheter but does not provide an occlusive seal against microbes nor does it effectively prevent movement of a catheter at its point of epidermal penetration.
The problem of infections associated with invasive medical devices are well recognized. Two examples of publications in the field of urinary infection and sepsis can be found in the work of Gillespie, W.A., Lennon, G.G., Linton, K.B., and Slade, N. "Prevention of Urinary Infection in Gynecology," British Medical Journal, August 1964, Volume 2, pages 423-425 ("Gillespie"), and Viant, A.C., Linton, K.B., Gillespie, W.A., Midwinter, A., "Improved Method for Preventing Movement of Indwelling Catheters in Female Patients," The Lancet, April, 1971, at pages 736-737 ("Viant").
Thus, it is recognized that immobilizing a catheter securely with respect to its entrance site and providing antiseptic or antimicrobial substances to the entrance site decreases the incidence of infections.
A review of ineffective or attempted solutions to catheter infection and sepsis that depict the state of the art of urinary sepsis and infection, can be found in the work of Kunin, C.M., "Henitourinary Infections in the Patent at Rick: Extrinsic Risk Factors," The American Journal of Mecicine, May 15, 1984, at pages 131-138 ("Kunin"). Kunin recognizes that an effective soution for preventing catheter-associated infections and sepsis is not yet available. Bacterial biofilm can provide microorganisms with a certain amount of immunity to antiseptic and/or antimicrobial substances. This has been recognized by Nickel, J. C., Downey, J. A. and Costerton, J. W. in "Ultrastructural Study of Microbiologic colonization of Urinary Catheters," Urology, vol. 34, pg. 284 (1989). Thus, even providing an antiseptic or antimicrobial substance to a medical apparatus penetration site often does not result in an effective zone of aseptic. However, the mechanical occlusion of bacteria from a wound or epidermal opening can prevent bacterial migration via deposition of a biofilm layer. An occlusive wound dressing may prevent the initial formation of a biofilm, layer in close proximity to a wound site or epidermal entry site of an invasive medical apparatus.
Systemic and local penetration site infections from invasive medical apparatus use are believed to result from one of two general causes: (1) intraluminal or intrinsic infections arising from bacteria that migrate internally through the lumen of the invasive medical apparatus to a situs of infection at the internal end of the invasive medical apparatus, and (2) extrinsic infections arise via the migration of bacteria along the external surface of the invasive medical apparatus.
The first means of infection does not apply to the use of solid invasive medical apparatus that do not permit intraluminal transmission. The latter means of infection is thought to be increased by the bacterial secretion of a thin film of mucopolysaccharide material known as "biofilm" along the external surface of an invasive medical apparatus. Bacteria multiplying within a biofilm layer traverse this surface. When such an organic exudate layer exists, the occurrence of infections is further increased by in-and-out motion of the invasive medical apparatus at the site of penetration.
Thus, reduction or elimination of invasive medical apparatus movement is desirable in order to substantially reduce invasive medical apparatus-associated infections. Devices which firmly affix an invasive medical apparatus in relation to its penetration site prevent movement of the invasive medical apparatus into, out of, or in-and-out of the penetration site. Until the present invention, none of the devices available provided effective means to solve the problems associated with invasive medical apparatus.